Week 8: Hazardous wastes + safe foods

Question 1

Solid and hazardous wastes:
1) How long is the garbage barge travel time?
2) Americans dispose of _______ million tons of municipal solid waste each year
*Does not include construction, demolition debris, automobile bodies, municipal sludges or industrial process wastes
3) Why do we care?

Answer 1

1) 5-month journey
2) 262 million
3) Rats, flies and diseases

Question 2

1) What made most incinerators illegal?
2) What outlawed dumping into rivers and lakes?
3) What made ocean dumping illegal?

Answer 2

1) Clean Air Act
2) Clean Water Act
3) Marine Protection, Research, and Sanctuaries Act of 1972

Question 3

Sanitary Landfills:
1) What do they require?
2) What allows for this?
3) What happens when at capacity?

Answer 3

1) Wastes to be confined in a sealed area
2) Dry, impervious clay soil, lined with plastic, vents for hazardous gases
3) It’s covered with a 2-foot layer of soil

Question 4

1) What is the cost to dispose of waste called?
2) What is the average cost?
3) Give an example of a former landfill and what’s being done with it

Answer 4

1) “Tipping Fee”
2) $60.34/ton
3) Fresh Kills Landfill on Staten Island
1948-2001
-Plan is to be a park in 2036

Question 5

Alternatives to Landfills:
1) __% of municipal solid waste is disposed in landfills
2) Why is Reduce, Reuse and Recycle so important?

Answer 5

1) 53%
2) Consumer behavior holds the key to reducing waste

Question 6

Alternatives to Landfills:
1) In 2015, ____% of municipal waste is recycled or composted nationwide
2) Refundable deposits are used in how many states?

Answer 6

1) 35%
2) 10 states

Question 7

1) Define hazardous wastes
2) What are 2 special categories?

Answer 7

1) Toxic to humans, plants or animals; likely to explode or are corrosive
2) Radioactive wastes
Infectious medical wastes

Question 8

1978 “Love Canal”:
1) Where was it located?
2) What very noticeable effects did it cause? Why?
3) What serious effects did it cause?
4) Why did these effects happen?

Answer 8

1) Niagara Falls, NY
2) Chemicals would seep into basements. Children developed rashes and watery eyes
3) Cancer, birth defects, miscarriages
4) 200 different chemicals found: benzene, pesticides, carcinogens…

Question 9

What regulates under law wastes? What 3 things does this include?

Answer 9

1) RCRA
2) Petroleum refining
Pesticide manufacturing
Pharmaceutical products

Question 10

1) What are the 2 key elements of hazardous waste management?
2) What do these do?

Answer 10

1) Tracking and permitting
2) Mandates paperwork document the progress
+ has to have a permit from the EPA or state

Question 11

Reducing Hazards
1) What are the 3 main ideas?
2) How is the third done?

Answer 11

1) Recycle, reuse and reduce
2) Reduce: treat at high temperatures, special containers under steal and concrete

Question 12

“Superfund”:
1) What did the Comprehensive Environmental Response, Compensation and Liability Act require? What year? How much money?
2) Who paid for this?
3) Was it reauthorized? If not, why? If so, when?

Answer 12

1) EPA to compile a priority list of waste sites (1980)
-1.6 billion over a 5-year period
2) Paid for by tax on industry
3) Reauthorized in 1986 and 1990

Question 13

What has been the controversy about “superfunding”? (4 things)

Answer 13

1) Cleanup has been slow
2) New sites get added more than old sites removed
3) Hard to pinpoint who is liable
4) Where to put it?

Question 14

1) It’s challenge to regulate millions of restaurants, grocery stores, vending machines, cafeterias etc. Why?
2) What did the 1906 federal food & drugs act do?

Answer 14

1) Food can be altered with cheaper materials and toxic additives
2) Provisions to control manufacturing, labeling and sale of drugs

Question 15

1) What organization was created to oversee the regulation of food and drugs?
2) What else does it now also oversee?

Answer 15

1) Food and Drug Administration (FDA)
2) Later cosmetics, medical devices, feed and drugs for animals

Question 16

1) What causes food-born illness?
2) What can allow this to happen?

Answer 16

1) Contamination of foods with bacteria, viruses or parasites
2) Due to breakdowns in sanitation and proper food handling practices.

Question 17

1) What 3 things is salmonella common in? What is salmonella’s weakness?
2) Escherichia coli 0157:H7 is widespread in what 4 things?

Answer 17

1) Common in poultry, meat and eggs; killed if properly cooked
2) Beef, lettuce, raw milk, and alfalfa sprouts

Question 18

Food-Born illness causes:
1) What causes Hep A? What is a key fact about it?
2) What details food-borne outbreaks?

Answer 18

1) Poor hygiene; contagious 10-14 days prior to symptoms
2) National Outbreak Reporting System (NORS)

Question 19

True or false: we don’t have a central location to control everything regarding food issues

Answer 19

True

Question 20

What creates inconsistencies in food issues in the US?

Answer 20

“Patchwork” legislation, division of responsibility and lack of coordination create inconsistencies

Question 21

Federal agencies
1) What group has overall responsibility for food safety regulation in the United States (seafood and produce)?
2) What responsibilities does the USDA have? What can they do?

Answer 21

1) FDA
2) Regulatory responsibilities for meat, poultry, and eggs in the United States
-Can ban importing meet and poultry from countries with inferior food safety systems

Question 22

Agencies and Their Role in Food Issues:
1) What are the state and local health department responsibilities?
2) What is the role of consumer protection agencies?

Answer 22

1) Conduct restaurant inspections, outbreak investigations
2) Provide education in safe food purchasing, preparation, and storage

Question 23

Federal agencies:
1) What does the EPA regulate and establish?
2) What does the CDC do?

Answer 23

1) Regulation of pesticide usage and the establishment of water quality standards
2) Not a regulatory agency; responsible for ongoing surveillance and acute investigations in collaboration with state and local health departments

Question 24

Temperature:
1) What temp allows for safe food?
2) What regulates it?

Answer 24

1) Below 40F or heated above 140F (meat dependent)
2) Periodic inspections of stores, restaurants and institutions

Question 25

1) How long has radiation been used to kill contaminants? 2) Give examples of how this is used 3) What does radiation require?

Answer 25

1) 40 years 2) Kills pests in dried herbs, spices and tea Controls parasites in pork Reduces salmonella and e.coli 3) Has to have a label on food

Question 26

What group was created in the 1960s to ensure foods for astronauts were safe?

Answer 26

Hazard Analysis Critical Control Point (HACCP)

Question 27

Hazard Analysis Critical Control Point (HACCP): 1) What does it NOT rely on? 2) What does it focus on and prioritize? 3) What does it require?

Answer 27

1) Does not rely on inspections 2) Procedures, prioritizing food businesses to identify potential sources of contamination 3) Analysis of every step in food production, processing and preparation

Question 28

Food Safety Modernization Act (2010) requires: 1) What of farmers and food processors? 2) What of foreign food suppliers? - ____% of fruits, ____% of vegetables and 80% of seafood are imported. 3) Regulation and inspection of what?

Answer 28

1) Maintain distribution records 2) To meet the same safety standards as domestic suppliers -50%; 20% 3) Regular inspection of all food processing facilities (Reduced regulation of locally produced food based on evidence that locally produced foods result in considerably less foodborne illness)

Question 29

What did the Food Safety Modernization Act (2010) ensure by giving the FDA and USDA more authority?

Answer 29

Ensures the ability to track foods including origin and date of production in case an outbreak source needs to be identified

Question 30

1) What group utilizes public health labs to do DNA “fingerprinting” of all food-borne bacteria? 2) Where is it located?

Answer 30

1) PulseNet 2) Labs in all 50 states and Canada

Question 31

1) What is Food Net? 2) What does it include?

Answer 31

1) Unlike passive surveillance, public health officials proactively seek out potential cases. 2) Investigators at the USDA, FDA, heath departments and the CDC

Question 32

The first step of Foodborne Outbreak Investigation is detecting a possible outbreak. What is the difference between a cluster and outbreak?

Answer 32

1) **Cluster:** a larger number of people than expected have the same illness in a given time period and area 2) **Outbreak:** When a cluster is determined and they have something in common to explain why they have the same illness

Question 33

Steps in Foodborne Outbreak Investigation: 1) What can happen when initially defining and finding cases? 2) What is a case definition?

Answer 33

1) Often, initial recognized illnesses are only part of the outbreak 2) A set of criteria used to define which persons will be considered to have a disease as part of an outbreak

Question 34

Steps in Foodborne Outbreak Investigation: 1) Generating hypotheses about likely sources should involve what when food exposure is suspected? 2) How should this be done?

Answer 34

1) Investigators narrowing the possible list of foods 2) Health officials interview persons who are/were ill regarding location, foods consumed, etc.

Question 35

Steps in Foodborne Outbreak Investigation: 1) What is the most common way to test the hypothesis? What occurs during this? 2) What else needs to be done during this phase?

Answer 35

1) Case-control studies -Investigators analyze information collected from ill and well people to determine whether ill persons were more likely than those who did not get sick to have eaten a certain food or report a particular exposure 2) Food testing

Question 36

Steps in Foodborne Outbreak Investigation: 1) When do investigators try to determine how the food was contaminated? 2) What is source traceback?

Answer 36

1) If a likely source is identified 2) Investigators work to find out where the contamination occurred and examine each step in the process of the food preparation

Question 37

Food safety standards limits contaminants and additives. Define contaminants.

Answer 37

Hair, dirt, rodent feces, insect parts

Question 38

Additives and Contaminants: Pesticide residue: 1) 1996 EPA established a “__________ level” for residues 2) Why?

Answer 38

1) “tolerance level” 2) Damages endocrine system, developing fetuses, infants and young children

Question 39

Additives and Contaminants: hormones + abx 1) What do antibiotics lead to? 2) What was used to promote growth? Why was it banned and when? 3) What is the exception to the ban?

Answer 39

1) Leads to antibiotic resistance 2) Estrogen to promote growth Can lead to cancers and premature menarche Banned in 1970s 3) Dairy cows

Question 40

Food safety standards limits contaminants and additives; give examples of contaminants and additives (both good and bad)

Answer 40

1) Food coloring (Some are carcinogenic) 2) Iodine in salt 3) Vitamin D in milk 4) Folic acid in flour/rice 5) Vitamin B in bread

Question 41

Give 4 examples of additives that aren't bad

Answer 41

1) Iodine in salt 2) Vitamin D in milk 3) Folic acid in flour/rice 4) Vitamin B in bread

Question 42

What is an example of a bad additive?

Answer 42

Food coloring

Question 43

What can cause pellagra?

Answer 43

Niacin deficiency

Question 44

1) What is the FDA responsible for regarding drugs? 2) What does the FDA regulate abt cosmetics?

Answer 44

1) Responsible for prescription and over-the-counter drugs, but does not test the drug (companies submit a report) 2) Loosely regulates; Does not need preapproval Other than color additives Warning label if not tested

Question 45

1) What are the steps of getting a new drug approved by the FDA? 2) Can approval be revoked?

Answer 45

1) File a New Drug Application (NDA) -Three phases of clinical trials -Phase 4: surveillance 2) Yes; can revoke approval on evidence

Question 46

What is phase 4 of approving a new drug? What can happen here?

Answer 46

Surveillance (technically this is post-approval); can revoke approval on evidence

Question 47

1) The Dalkon Shield (an IUD) produced what? 2) What did this lead to?

Answer 47

1) Thousands of cases of infection and infertility 2) Increased regulation of medical devices in the mid-1970s

Question 48

Thalidomide (sedative used for treating morning sickness in pregnant women that was causing birth defects in other countries) approval was delayed in the early 1960s. What happened in response to this, and what did this lead to?

Answer 48

The Kefauver-Harris Drug Amendments were established (to the FD&C) -Led to mandated efficacy testing before a drug could be approved and marketed -Served as the foundation of today’s drug approval process

Question 49

FDA required animal safety studies: 1) What is required? 2) What kinds of studies?

Answer 49

1) Administered to two different species at levels well above the equivalent dose expected to be used in humans 2) Studies done to detect cancer, teratogenicity, and effects on fertility and on drug-sensitive organs such as kidneys, liver, and bone marrow

Question 50

Effects on animal may fail to detect the effects on humans or demonstrate high-dose effects. 1) Give an example 2) Why may this occur?

Answer 50

1) Thalidomide did not demonstrate the severe limb shortening in animal testing 2) Humans may absorb, metabolize, and excrete drugs differently than animal species (so not a perfect method)

Question 51

1) Initial administration of a drug to human beings occurs when? 2) What does this phase focus on? 3) What does it establish? 4) What does it look at?

Answer 51

1) Phase 1 2) The pharmacology of the drug (absorption, metabolism, and excretion) 3) The dosage range and route of administration to be used in subsequent studies 4) Safety issues

Question 52

1) What are phase 1 trials capable of identifying? What specifically is the focus? 2) Give examples

Answer 52

1) Common and series side effects -The effects on organs that are known to be especially sensitive to the actions of drugs 2) Liver, kidney, bone marrow, testicles

Question 53

Phase 1 trials: 1) What may they focus on based on the known actions of a particular class of drugs or a particular drug? 2) Give an example 3) What is the duration and study size? 4) What is a major limitation of this phase?

Answer 53

1) Expected effects 2) When testing a new antidepressant, examine the electrical conduction system of the heart because antidepressants are known to produce arrhythmias 3) Duration of the exposure to the drug likely short and the study is usually small (*no pregnant women or young children) 4) Wide rage of special sensitivities to drug actions that occur among a small number of people

Question 54

1) What are phase 3 studies? What is this the gold standard for? 2) What are they designed around? 3) What is a key limitation? Explain

Answer 54

1) Randomized controlled trials (*gold standard for establishing efficacy for one particular indication) 2) The specific requirements for determining efficacy for a particular disease on a particular type of patient 3) Establishing safety *Trials are too small, too short, too simple

Question 55

1) New drugs are approved based on what? 2) What do phases 1-3 NOT do?

Answer 55

1) Data collected in preclinical testing and phases 1,2,3 2) Do not establish that the drug has effectiveness

Question 56

Phase 4 1) What system is in place here? Explain 2) Give an example

Answer 56

1) Spontaneous reporting system: Prescribers and patients are encouraged (not a requirement) to report side effects to the FDA 2) Ex: new rotavirus vaccine caused intussusception in a small number of cases a few weeks after it was given -Convincing evidence that the intussusception was due to the vaccine included: unusual nature of the side effect, dramatic presentation, and clear time relationship with the vaccine

Question 57

Phase 4: Who need to be thought of as part of the experiment?

Answer 57

Patients who receive a new treatment over the first few months to few years after the initial marketing approval

Question 58

FDA approval implies the new drug may be __________ and ______________ for a particular indication.

Answer 58

advertised and marketed

Question 59

FDA approval implies what 3 things about a new drug?

Answer 59

1) May be advertised and marketed for a particular indication. 2) May be used by prescribing clinicians who have the authority to use the treatment for indications or at dosages not specifically approved by the FDA 3) Off-label prescribing: The use of FDA approved drugs for indications or at dosages not approved by the FDA

Question 60

Food and Drug Labeling and Advertising 1) What required accurate labeling? 2) What required labels on prepared foods? 3) When did we add trans fats to labels? What year were they banned from food?

Answer 60

1) Pure Food and Drugs Act of 1906 2) 1994 3) 2006; 2015

Question 61

Food and Drug Labeling and Advertising: 1) What does the FDA oversee? How is this different from the FTC? 2) What forbids the FDA from testing herbs and food supplements? 3) In what year did a law pass requiring supplement manufactures to report serious adverse effects to the FDA?

Answer 61

1) FDA also oversees advertising on prescription drugs Federal Trade Commission (FTC): Oversees advertising with OTC drugs 2) 1994 Dietary Supplement Health and Education Act 3) 2007

Question 62

Politics of the FDA: 1) How much does it regulate? 2) Who place political pressures on Congress/White House?

Answer 62

1) Products that account for more than 25% of all consumer dollars spent in the U.S. 2) Industries

Question 63

Politics of the FDA: List the controversies

Answer 63

1) “Too Slow” in approving new drugs 2) Importing from other countries: Highest is China and India (60%) of generic and OTC drugs used in the W.S. -Does not undergo the same inspections; 2008 Heparin recall from China killed 62 people